NCT04766333

Brief Summary

This mixed methods study evaluates the effectiveness and cost of a healthcare worker focused outreach intervention strategy versus community organization led outreach to explore contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,017

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 10, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

February 10, 2021

Results QC Date

February 10, 2023

Last Update Submit

March 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Complete COVID-19 Testing

    Number of participants who return their saliva testing kit.

    1 year

Study Arms (2)

Healthcare Worker Focused Outreach Intervention Strategy

ACTIVE COMPARATOR

Healthcare Worker Focused Outreach Intervention Strategy

Behavioral: Healthcare Worker Focused Outreach

Community Organization Led Outreach

ACTIVE COMPARATOR

Community Organization Led Outreach

Behavioral: Community Organization Led Outreach

Interventions

This a focused outreach intervention strategy specifically designed for healthcare workers.

Also known as: Informational intervention
Healthcare Worker Focused Outreach Intervention Strategy

This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach.

Also known as: Informational intervention
Community Organization Led Outreach

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identification as Black or Hispanic/Latino.
  • Resident of Union, Passaic, Middlesex, or Essex County, NJ.
  • Parent/legal guardian able to provide permission to participate for those under 18

You may not qualify if:

  • Under 4 years of age.
  • Unable to speak, understand, and/or read English or Spanish.
  • Unable to provide informed consent/assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (4)

  • Jimenez ME, Rivera-Nunez Z, Crabtree BF, Hill D, Pellerano MB, Devance D, Macenat M, Lima D, Martinez Alcaraz E, Ferrante JM, Barrett ES, Blaser MJ, Panettieri RA Jr, Hudson SV. Black and Latinx Community Perspectives on COVID-19 Mitigation Behaviors, Testing, and Vaccines. JAMA Netw Open. 2021 Jul 1;4(7):e2117074. doi: 10.1001/jamanetworkopen.2021.17074.

    PMID: 34264327BACKGROUND
  • Barrett ES, Andrews TR, Roy J, Greenberg P, Ferrante JM, Horton DB, Gordon M, Rivera-Nunez Z, Pellerano MB, Tallia AF, Budolfson M, Georgopoulos P, Reed D, Lynn B, Rosati R, Castaneda M, Dixon F, Pernell C, Hill D, Jimenez ME, Blaser MJ, Panettieri R Jr, Hudson SV. Community- Versus Health Care Organization-Based Approaches to Expanding At-Home COVID-19 Testing in Black and Latino Communities, New Jersey, 2021. Am J Public Health. 2022 Nov;112(S9):S918-S922. doi: 10.2105/AJPH.2022.306989. Epub 2022 Oct 20.

    PMID: 36265092BACKGROUND
  • Rivera-Nunez Z, Jimenez ME, Crabtree BF, Hill D, Pellerano MB, Devance D, Macenat M, Lima D, Gordon M, Sullivan B, Rosati RJ, Ferrante JM, Barrett ES, Blaser MJ, Panettieri RA Jr, Hudson SV. Experiences of Black and Latinx health care workers in support roles during the COVID-19 pandemic: A qualitative study. PLoS One. 2022 Jan 18;17(1):e0262606. doi: 10.1371/journal.pone.0262606. eCollection 2022.

    PMID: 35041702BACKGROUND
  • Juarez R, Phankitnirundorn K, Ramirez A, Peres R, Maunakea AK, Okihiro M. Vaccine-Associated Shifts in SARS-CoV-2 Infectivity Among the Native Hawaiian and Other Pacific Islander Population in Hawaii. Am J Public Health. 2022 Nov;112(S9):S896-S899. doi: 10.2105/AJPH.2022.306973. Epub 2022 Sep 15.

MeSH Terms

Conditions

COVID-19Patient Acceptance of Health CareHealth Behavior

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTreatment Adherence and ComplianceBehavior

Results Point of Contact

Title
Shawna V. Hudson
Organization
Rutgers University

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Research Division Chief Department of Family Medicine and Community Health

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 23, 2021

Study Start

May 3, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 10, 2023

Results First Posted

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations